potti65 : heute FDA
First, a decision was due February 25. The FDA said it needed 3 more months to review data. The decision was then due on May 25, but on May 26 word came out that "staff scheduling changes" had delayed the final report. 1-2 more weeks, the FDA said.
The 2 weeks were up yesterday, and still we have no word on whether Ampligen will become the first drug ever approved for chronic fatigue syndrome. With widespread skepticism and cynicism about the FDA, don't you think the agency would at least try to get word out on time? Do these folks realize that millions of very sick people are waiting for access to better treatments? Wouldn't you think they'd at least -- in the interest of good PR -- put out some kind of statement if they're going to be late?
It would be one thing if this was a rare occurrance, but it wasn't long ago that they kept fibromyalgia patients waiting for a decision on Savella (milnacipran). A decision was due in October, but after that deadline passed the FDA said it needed more time, then made no further comment for 3 months.
It's not that I think Ampligen, or any other drug, is going to come along and work miracles for everyone with chronic fatigue syndrome. At best, it'll be an effective treatment for a few subgroups, and tolerable to a fair number of those. What gets me is that this agency utterly disregards its own deadlines and can't even be bothered to let people know what's going on. Knowing that this latest delay is all because a major government agency can't handle its own scheduling makes me all the more angry about it.
Of course, there's been a lot of buzz on Wall Street and the financial blogs about Ampligen, both positive or negative. Here's an interesting editorial I thought would address some of the points that have been raised here and elsewhere over the past week: Hemispherx's Ampligen: Fact vs. Fiction. It's a response to this article: Hemispherx Builds False Hope on Old Data.
I've sent a several emails to folks at the FDA asking when we should know, and I'm watching for an announcement. I'll let you know as soon as I know.
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